U.S. patent number 8,692,119 [Application Number 13/670,057] was granted by the patent office on 2014-04-08 for device for analysis of a sample on a test element.
This patent grant is currently assigned to Roche Diagnostics Operations, Inc.. The grantee listed for this patent is Roche Diagnostics Operations, Inc.. Invention is credited to Manfred Augstein, Gregor Bainczyk, Albert Grosser, Oliver Kube, Dieter Meinecke, Stefan Riebel, Bruno Thoes, Herbert Wieder.
United States Patent |
8,692,119 |
Riebel , et al. |
April 8, 2014 |
Device for analysis of a sample on a test element
Abstract
An analysis device for analysis of a sample on a test element is
provided that comprises at least one component configured to make
electrical contact with at least one other component for electrical
transmission therebetween. The at least one component generally
comprises an injection-molded circuit mount, also called an MID, or
molded interconnect device.
Inventors: |
Riebel; Stefan (Cham,
CH), Augstein; Manfred (Mannheim, DE),
Bainczyk; Gregor (Mannheim, DE), Grosser; Albert
(Dusseldorf, DE), Kube; Oliver (Worms, DE),
Meinecke; Dieter (Mannheim, DE), Thoes; Bruno
(Quierschied, DE), Wieder; Herbert (Mannheim,
DE) |
Applicant: |
Name |
City |
State |
Country |
Type |
Roche Diagnostics Operations, Inc. |
Indianapolis |
IN |
US |
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Assignee: |
Roche Diagnostics Operations,
Inc. (Indianapolis, IN)
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Family
ID: |
36043343 |
Appl.
No.: |
13/670,057 |
Filed: |
November 6, 2012 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20130062202 A1 |
Mar 14, 2013 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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12105993 |
Dec 11, 2012 |
8330046 |
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PCT/EP2006/067709 |
Oct 24, 2006 |
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Foreign Application Priority Data
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Oct 25, 2005 [EP] |
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05023219 |
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Current U.S.
Class: |
174/126.4;
204/406; 204/297.1; 174/250 |
Current CPC
Class: |
G01N
33/48785 (20130101); A61B 5/14532 (20130101) |
Current International
Class: |
H01B
5/14 (20060101) |
Field of
Search: |
;204/406,297.06-297.16
;174/126.4,250-268 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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19717882 |
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Nov 1998 |
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DE |
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19753847 |
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Jun 1999 |
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DE |
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19854316 |
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Oct 1999 |
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DE |
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19831394 |
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Mar 2000 |
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DE |
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19902601 |
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Jul 2000 |
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DE |
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10255325 |
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Jun 2004 |
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DE |
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10359160 |
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Jul 2005 |
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DE |
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0618443 |
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Mar 1994 |
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EP |
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0732590 |
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Jan 1996 |
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EP |
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0821233 |
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Jul 1997 |
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EP |
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0821234 |
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Jul 1997 |
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EP |
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0505475 |
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Mar 1999 |
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EP |
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1457913 |
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Jul 1999 |
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EP |
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1079379 |
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Feb 2001 |
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EP |
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1383360 |
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Jul 2002 |
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EP |
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8262026 |
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Oct 1996 |
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JP |
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2001052371 |
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Feb 2001 |
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JP |
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2005186623 |
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Jul 2005 |
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JP |
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WO 85/02257 |
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May 1985 |
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WO |
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WO 97/02487 |
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Jan 1999 |
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WO |
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WO 00/19185 |
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Apr 2000 |
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WO |
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WO 00/67982 |
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Nov 2000 |
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WO |
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WO 01/48461 |
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Jul 2001 |
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WO |
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Other References
K Feldman et al., "New Requirements and Solutions for Product Data
Processing of Three-Dimensional Molded Interconnection Devices",
IEEE Int'l Electronics Manufacturing Technology Symposium, 1992,
pp. 94-99. cited by applicant .
G. Spanier et al., "Biocompatible Assembling and Packaging
Technology Demonstrated by the Integration of a Micro Sensor on a
Micro Blood Pump", Proceeding of IEEE Sensors 2003, 2nd IEEE
International Conference on Sensors, Toronto, Canada, Oct. 2003
vol. 2, Conf. 2, pp. 991-995. cited by applicant .
Erik Jung et al., "Packaging of an Electronic-Microfluidic Hybrid
Sensor", Proceedings 53rd Electronic Components and Technology
Conference, New Orleans, May 2003, Proceeding of the Electronic
Components and Technology Conference, New York, vol. 53, May 2003,
pp. 373-376. cited by applicant .
M. Eisenbarth et al., "Pressfit Technology for 3-D Molded
Interconnect Devices (MID)--A lead-free Alternative to Solder
Joints--Challenges and Solutions Concepts", IEEE/SEMI Technology
Symposium: International Electronics Manufacturing Technology
(IEMT) Symposium, 2002, pp. 238-244. cited by applicant .
David C. Frisch, "Circuitry in Three Dimensions: Multifunctional
Molded Plastic Packages", IEEE Transactions on Industry
Applications, vol. 27, No. 3, May/Jun. 1991, pp. 442-446,
XP-002374388. cited by applicant .
Penta Media: "Molded Interconnect Devices Reshape Electromechanical
Design", Online, Sep. 2000, pp. 1-7, XP002374387. cited by
applicant .
Frank Poehlau, "Raeumliche Schaltungstraeger--Rationalisieren durch
Integration (3-Dimensional Circuit Carriers-Rationalization through
Integration)", Siemens-Webzine, Online Nr. Jan. 1997, pp. 1-6,
XP002374386. cited by applicant .
Machine translation to English of DE 19717882 A1. cited by
applicant .
Document entitled "Our Comments", discussing Japanese references,
2011, 5 pages. cited by applicant.
|
Primary Examiner: Ball; J. Christopher
Attorney, Agent or Firm: Krieg DeVault LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application is a continuation of U.S. patent
application Ser. No. 12/105,993 filed on Apr. 18, 2008, which is a
continuation of and claims priority to PCT Application No.
PCT/EP2006/067709, filed Oct. 24, 2006, which in turn claims the
priority benefit of European Patent Application No. 05023219.8,
filed Oct. 25, 2005, each of which are hereby incorporated by
reference in their entireties.
Claims
What is claimed is:
1. An analysis device for analysis of a sample on a test element,
comprising at least one first component configured to make
electrical contact with at least one second component for
electrical transmission therebetween, wherein the first component
comprises an injection-molded circuit mount, wherein the first
component has at least one sprung contact lug, configured to make
contact with the second component, which sprung contact lug
comprises a contact lug body comprising an injection-molded plastic
and a metallic electrical conductor structure, wherein the contact
lug is configured to make electrical contact with a rotating second
component of the analysis device.
2. The analysis device of claim 1, wherein the electrical contact
of the first component with the second component comprises a type
of electrical contact selected from the group consisting of sprung
contact, plug-in contact, solder contact, sliding contact and
conductive-adhesive contact.
3. The analysis device of claim 1, wherein the first component
comprises a functional assembly of the analysis device, and wherein
the second component comprises a printed circuit board of the
analysis device.
4. The analysis device of claim 3, wherein the functional assembly
comprises a component selected from the group consisting of a
barcode reader arrangement, a transport unit for test elements, a
motor module, a measurement module, a positioning device for a test
element magazine, a test element magazine holder which contains a
sensor, and a heat-treatment device.
5. The analysis device of claim 1, wherein the first component
comprises a contact element for test element evaluation of the
analysis device, and the second component comprises a test element
configured to be evaluated electrochemically.
6. The analysis device of claim 5, wherein the contact element for
test element evaluation is integrated in a test element
magazine.
7. A method for producing an analysis device for analysis of a
sample on a test element, comprising: producing at least one first
component configured to make electrical contact with at least one
second component for electrical transmission therebetween, the
first component comprising a base body and a metallic conductor
structure, said producing being performed according to a method for
producing injection-molded circuit mounts, wherein the first
component has at least one sprung contact lug, configured to make
contact with the second component, which spring contact lug
comprises a contact lug body comprising an injection-molded plastic
and a metallic electrical conductor structure, wherein the contact
lug is configured to make electrical contact with a rotating second
component of the analysis device; and positioning and mounting the
first component in the analysis device.
8. The method of claim 7, wherein the method for producing
injection-molded circuit mounts comprises a method selected from
the group consisting of two-component injection-molding, hot
stamping, in-mold film coating and laser structuring.
9. The method of claim 7, wherein the electrical contact of the
first component with the second component comprises a type of
electrical contact selected from the group consisting of sprung
contact, plug-in contact, solder contact, sliding contact and
conductive-adhesive contact.
10. The method of claim 7, wherein the first component comprises a
functional assembly of the analysis device, and wherein the second
component comprises a printed circuit board of the analysis
device.
11. The method of claim 10, wherein the functional assembly
comprises a component selected from the group consisting of a
barcode reader arrangement, a transport unit for test elements, a
motor module, a measurement module, a positioning device for a test
element magazine, a test element magazine holder which contains a
sensor, and a heat-treatment device.
12. The method of claim 7, wherein the first component comprises a
contact element for test element evaluation of the analysis device,
and the second component comprises a test element configured to be
evaluated electrochemically.
13. The method of claim 12, wherein the contact element for test
element evaluation is integrated in a test element magazine.
Description
TECHNICAL FIELD OF THE INVENTION
The present invention pertains to an analysis device for analysis
of a sample on an analytical test element, which contains at least
one component which makes electrical contact for transmission of
electrical power, and in particular the present invention pertains
to such devices in which the at least one component comprises an
injection-molded circuit mount such as a molded interconnect
device.
BACKGROUND
Samples, for example bodily fluids such as blood or urine, are
frequently analyzed using analysis devices in which the samples to
be analyzed are located on a test element and may react with one or
more reagents on the test element in a test area before they are
analyzed. The optical, in particular photometric evaluation, and
the electrochemical evaluation of test elements represent the most
usual methods for rapid determination of the concentration of
analytes in samples. Analysis systems with test elements for sample
analysis are generally used in the field of analysis, environmental
analysis and in particular in the field of medical diagnosis.
Particularly in the field of blood glucose diagnosis from capillary
blood, test elements which are evaluated photometrically or
electrochemically play a major role.
There are various forms of test elements. By way of example,
essentially square platelets are known, which are also referred to
as slides, in whose center a multilayer test area is located.
Diagnostic test elements which are in the form of strips are
referred to as test strips. The prior art extensively describes
test elements, for example in the documents DE-A 197 53 847, EP-A 0
821 233, EP-A 0 821 234 or WO 97/02487, the disclosures of which
are hereby incorporated herein by reference in their entireties.
The present invention relates to test elements in any desired form,
including test elements in the form of strips.
Test element analysis systems which contain a test element holder
for positioning of the test element in a measurement position, and
a measurement and evaluation device for carrying out a measurement
and for determining an analysis result resulting from this are
known from the prior art for analytical investigation of a sample
on a test element, including WO 00/19185, the disclosure of which
is hereby incorporated by reference herein in its entirety.
Further analysis devices are known, for example, from EP 0 618 443
A1 or WO 01/48461 A1, the disclosures of which are hereby
incorporated by reference herein in their entireties.
Another exemplary system is the ACCU-CHEK.RTM. Compact Plus blood
glucose analysis system developed by Roche Diagnostics which
measures the blood glucose value using the photometric measurement
principle. A color change in a test area on a test element which
has previously been wetted with the blood of a patient is in this
case detected by an optical measurement module and is
electronically converted in the device to a value which is
proportional to the blood glucose. The measurement process is
started using a switch-on button. A motor in a motor module then
rotates the drum, which is used as a supply container, with the
test elements around a chamber of the supply container further, and
a second motor uses a push rod to push a test element out, so that
it can be wetted with blood by the user, outside the device. During
the process, the test element remains so far in the analysis device
that the test area with the indicator chemistry is positioned over
the measurement optics in the measurement module. The measurement
optics comprise two diodes, a photocell and a lens. The change in
the diffuse reflection is converted by the photocell to a signal
current which is processed by an electronic circuit on a printed
circuit board, and is displayed as blood glucose value on an LC
display. The measurement process is ended by operating the
switch-on button again, pushing out the test element and switching
the analysis device off. The measurement and drive electronics are
supplied with a total voltage of about 3 V from two batteries. In
contrast to comparable analysis devices, into which, for example,
test elements are supplied from the outside and individual
intermediate states have to be operated manually, this device has
greater functional integration. Seventeen individual test elements
are mounted in the supply container, which is in the form of a
drum, and the specification for the test elements is identified
automatically by means of a barcode reader in the analysis device.
A change in the test element magazine, which is in the form of a
drum, is detected via a switch on the housing upper part after
opening and closing of the test element magazine holder cover. The
required states, such as rotation of the test element magazine
through one step and various holding positions during the forward
movement of the test element are signaled via sliding contacts and
dynamically sprung switching contacts to the electronics on the
printed circuit board, without any control function being required
by the user. In this context, "dynamically sprung" means force
loading and unloading and repeated linear movement during
operation. The core of the analysis device for carrying out these
electromechanical functions is formed by the motor module. This is
used, inter alia, to hold the drive motors and the transmission
board. The printed circuit board is screwed to the motor module.
For this purpose, all the other contacts between these two
assemblies are in the form of detachable static spring contents,
for example the contacts for the electrical power supply for the
drive motors and for the measurement module. In this context,
"statically sprung" means single force loading and linear movement
during device assembly. The printed circuit board has four layers,
because of the numerous functions which are integrated in the
device and must be controlled by the device software.
The analysis devices known in the prior art have a multiplicity of
components which make electrical contact. For example, sprung
contacts, plug-in contacts, solder contacts or sliding contacts
which connect the assemblies printed circuit board, motor module,
measurement module, drum cover switch, barcode reader and LCD to
one another, are known from the Roche Diagnostics Accu-Chek.RTM.
Compact Plus. Metallic stamped and bent parts are used for this
purpose in the prior art, which must be positioned and mounted on
the individual assemblies, thus resulting in a large number of
individual components, a large amount of assembly effort, and long
tolerance chains. Furthermore, the design freedom of the component
which makes electrical contact is restricted when using stamped and
bent parts, and often requires larger than desired form factors for
the analysis device as a result of the larger and more numerous
components.
The object of the present invention is therefore to avoid the
disadvantages of the prior art and to provide an analysis device
for analysis of a sample on a test element with components which
make electrical contact, by ensuring that reliable electrical
contact is made with a smaller number of individual parts to be
fitted.
SUMMARY
According to the invention, this object is achieved by an analysis
device for analysis of a sample on a test element, containing at
least one component which makes electrical contact for electrical
power or signal transmission and is suitable for making an
electrical contact with at least one further component. The
component which makes electrical contact is in this case an
injection-molded circuit mount (also referred to as a "molded
interconnect device" or "MID" or "MID component"). In one
embodiment, the component comprises a three-dimensional
injection-molded circuit mount.
The analysis device according to the invention can analyze a sample
on a test element, for example photometrically and/or
electrochemically.
In the analysis device according to the invention, at least one
component which makes electrical contact is in the form of a
three-dimensional, injection-molded circuit mount which can be
produced using one of the methods described herein. The component
which makes electrical contact is suitable for producing an
electrical contact with at least one further component. In various
embodiments, the type of electrical contact can comprise any of a
sprung contact, plug contact, sliding contact, solder contact or
conductive-adhesive contact. On the basis of an electrical contact
such as this, conductor tracks on an injection-molded circuit mount
(MID component) lead to an electrical component, for example a
sensor, a barcode reader, a further contact, a motor etc. Contacts
with both single and multistatic sprung contacts which make contact
are referred to as sprung contacts.
According to one embodiment of the present invention, the component
which makes electrical contact has at least one sprung contact lug
for making contact with the second component, which sprung contact
lug comprises a contact lug body composed of injection-molded
plastic and a metallic electrical conductor structure. By way of
example, PEI (polyetherimide), PA (polyamide), LCP (liquid-crystal
polymer), ABS (acrylonitrile butadiene styrene), PC
(polycarbonate), PC+ABS (polycarbonate+acrylonitrile butadiene
styrene), PBT (polybutyleneterephthalate), PI (polyimide) or PET
(polyethyleneterephthalate) may be used as the injection-molded
plastic, and, for example, copper, gold or nickel may be used for
the metallic electrical conductor structure. The contact lug may
make contact with a static, a rotating or a linearly moving further
component of the analysis device, in or on the analysis device.
In the analysis device according to the invention, the component
which makes contact and is in the form of an injection-molded
circuit mount may, for example, be a functional assembly of the
analysis device, and the further component, with which electrical
contact is made, may be a printed circuit board of the analysis
device. Functional assemblies in this case are, for example, a
barcode reader arrangement, a housing, a transport unit for test
elements, a motor module, a measurement module, a positioning
device for a test element magazine, a test element magazine holder
which contains a sensor, or a heat-treatment device in a
measurement module. The following are several comparative examples
of how certain functional assemblies are included in the prior art
and how the same functional assemblies are included in embodiments
of the present invention. The comparisons are illustrative only and
descriptions of embodiments of the present invention including such
functional assemblies is not intended to limit the scope of the
present invention except as otherwise may be recited in the claims
appended to this specification.
A barcode reader arrangement is, for example, contained in the
analysis device according to the invention, in order to use the
barcode reader to read a barcode on a supply container for test
elements which, for example, contains information about the test
elements contained therein, and about their optimum evaluation. In
the prior art, the barcode reader is normally attached to a printed
circuit board arm which projects into a housing section of the
analysis device in which a supply container for test elements (test
element magazine) may be held. Electrical contact is made with the
barcode reader via the lengthened printed circuit board arm, in
this case.
In contrast to this, the analysis device according to one
embodiment of the invention which is desired to have a barcode
reader functional assembly contains a barcode reader arrangement
which comprises a housing section of the analysis device in which a
barcode reader is arranged, with the housing section containing
conductor tracks which run to the barcode reader, and sprung
contacts for making contact with a printed circuit board, and with
the housing section with the conductor tracks and sprung contacts
being an injection-molded circuit mount, in particular a
three-dimensional injection-molded circuit mount. In this
embodiment, there is no need for the lengthened printed circuit
board arm. The barcode reader is connected directly to the housing
section (for example by a solder contact) in the housing interior.
The housing section itself contains the required conductor tracks
and a statically sprung contact for making contact with the printed
circuit board, in order to ensure the electrical power supply for
the barcode reader. This saves components and assembly steps,
resulting in more physical space within the analysis device.
In other embodiment, a positioning device for a test element
magazine may be required, such as for automatic removal of a test
element from, a test element drum magazine, in order to allow
specific access to the test element. A positioning device such as
this might, for example, rotate a test element magazine which is in
the form of a drum and may be designed as described such as in DE
198 54 316 A1, the disclosure of which is hereby incorporated by
reference in its entirety. As soon as the test element magazine is
correctly positioned, a test element can be removed from it by a
transport unit, and can be transported further in the analysis
device.
In the prior art, a positioning device for a test element magazine
in the form of a drum is designed, for example, such that a drum
wheel which is provided as a drive wheel for the test element
magazine rotates with the test element magazine, and the drum
rotation is registered by two spring contacts, which are hot-swaged
to a transmission board, and a segmented sliding ring on the drum
wheel (a total of five individual components to be fitted).
According to one embodiment of the present invention, an analysis
device according to the invention might contain a positioning
device for a test element magazine, which positioning device
comprises a board for supplying electrical power (including
electrical signals) and a drive wheel, which is driven by a motor,
for driving the rotatable test element magazine, with the board
being designed with spring contacts as an injection-molded circuit
mount, and with the drive wheel being formed with a segmented disk,
with which electrical contact can be made, as an injection-molded
circuit mount. The five individual components are therefore
replaced by two MID components. In this case, furthermore, this
offers the advantage of more flexible configuration of the physical
space in the analysis device according to the invention, by freer
shaping of a plastic part and of the conductor tracks arranged on
it, using MID technology.
A transport unit for test elements is used in an analysis device
for analysis of a sample on a test element for transport of a test
element in the analysis device, for example from a test element
magazine to a sample feed position and to a measurement position.
One such transport unit is known, for example, from DE 199 02 601
A1 relating to removing an analytical consumable, in particular a
test element, from a supply container with chambers which are
closed by films and from which the consumable is pushed out by a
plunger, the disclosure of which is hereby incorporated herein by
reference in its entirety.
The plunger (push rod) is moved in the axial direction by a motor.
In this disclosure, the push rod has a guide bush at one end, which
is guided in a guide device during movement of the push rod. The
guide device has a contact component which is in the form of a
stamped and bent part and has three contact lugs which are used to
position the guide bush and therefore the push rod. Depending on
the position of the guide bush, the contact lugs are pressed by the
guide bush against contact surfaces on a printed circuit board.
According to one embodiment of the present invention, the analysis
device according to the invention contains a transport unit for
test elements, which transport unit comprises a push rod for
transport of a test element within the analysis device, with the
push rod having a guide bush which can be guided in a guide device
during transport of the test element. In this case, the guide bush
has sprung contact lugs for making contact with a printed circuit
board, and the guide device has switching elements which are
arranged such that they press the contact lugs against the printed
circuit board in specific positions of the guide bush in the guide
device, with the guide bush with the contact lugs being an
injection-molded circuit mount (in particular a three-dimensional
injection-molded circuit mount). The switching function is
therefore integrated in the guide bush, whose contact lugs are, for
example, pressed by injection-molded switching studs on the guide
device against the printed circuit board contacts. This not only
saves manufacturing, positioning and assembly steps in comparison
to the prior art, but it is also possible to save space in the
corresponding configuration of the guide bush.
Largely automated analysis devices for analysis of a sample on a
test element in the prior art contain motor modules which have
motors. These motors are electric motors and are used, for example,
for positioning a test element magazine or for driving a push rod
which moves a test element within the analysis device.
In the prior art, a contact plate is pressed into a motor holder in
order to supply electrical power to a motor (drum motor or push-rod
motor), with the contact plate having produced an electrically
conductive connection to a printed circuit board via sprung contact
lugs.
According to one embodiment of the present invention, the analysis
device according to the invention contains a motor module which
comprises a motor and a motor holder, with the motor holder having
contact lugs for making contact with a printed circuit board, and
with the motor holder with the contact lugs being an
injection-molded circuit mount, in particular a three-dimensional
injection-molded circuit mount. The contact lugs of the MID part
may be soldered to a printed circuit board. Manufacturing and
assembly steps can be saved by using the injection-molded circuit
mount. In particular, the motor holder can be made simpler since,
for example, there is no need for injection-molded domes for
holding the separate contact plate.
An analysis device for analysis of a sample on a test element,
which can hold a test element magazine in a test element magazine
holder in order to supply a multiplicity of test elements, may
also, according to the invention, contain a sensor in the test
element magazine holder which detects any change in the test
element magazine. In the case of analysis devices from the prior
art, a change in the magazine is registered as soon as the analysis
device cover, which covers the test element holder, is opened and
then closed, since a locking switch on the printed circuit board is
operated during this process. However, if the analysis device cover
is opened and closed without the magazine being changed, the device
registers a magazine change even though this has not taken place.
In consequence, the magazine is rotated for identification by the
barcode reader and in order to find a chamber which is filled with
the test element without this being necessary. A sensor for
detecting an actual magazine change is not provided in the prior
art since the point at which the magazine change would be detected
cannot be accessed via the two-dimensional printed circuit board
provided in the analysis device, and it is not financially feasible
to make contact, for example via soldered-on, flexible cables.
According to one embodiment of the present invention, the analysis
device according to the invention comprises a test element magazine
holder which contains a sensor and contains electrical conductor
tracks which run to the sensor, with the test element magazine
holder with the conductor tracks being an injection-molded circuit
mount, in particular a three-dimensional injection-molded circuit
mount. A signal can then be passed via electrical conductor tracks
to the printed circuit board if the sensor has been activated, for
example by closing a contact on removal of the magazine.
An analysis device for analysis of a sample on a test element may
contain a heat-treatment device in order to heat treat a test
element before and during analysis (for example for a measurement
of blood clotting). Both heaters on the device side (for example in
a measurement module in which a measurement is carried out with the
sample on the test element) and heating elements integrated in the
test element (for example from DE 103 59 160 A1 the disclosure of
which is hereby incorporated by reference herein in its entirety)
are known in the prior art. Heaters on the device side may be
ceramic elements which are mounted in the test element holder or
are incorporated in the test element holder during its production
process. Fitted heating elements frequently lead to leakage
problems, however. It is possible for a liquid to enter the device,
and lead to damage. Further problems occur when contamination
occurs from sample material. Furthermore, a plurality of assembly
steps are necessary in order to obtain the finished assembly. The
use of ceramic heaters generally has the disadvantage that ceramic
can fracture, so that the serviceability of the device is not
ensured. Furthermore, the use of integrated ceramic heaters places
stringent demands on the manufacturing methods that are used, and
considerably increases their complexity.
According to one embodiment of the present invention, the analysis
device according to the invention contains a test element holder
for holding a test element (for example during a measurement),
which contains a heat-treatment device for heat-treatment of the
test element, with the heat-treatment device comprising heating
filaments and being an injection-molded circuit mount, in
particular a three-dimensional injection-molded circuit mount. The
conductor tracks which are used as heating filaments are therefore
integrated directly by means of MID technology in the plastic of
the test element holder. There is no need for integration of a
ceramic heater. The contacts for supplying electrical power to the
heating filaments may be produced, for example, from metallic
stamped or bent parts or likewise by means of the MID method. They
allow a heat-treatment device to be connected to a printed circuit
board for supplying electrical power. The advantages of this
embodiment of the analysis device according to the invention with a
heat-treatment device are simplicity of the production process,
avoidance of problems resulting from ceramic fracture, reduction in
the production costs by the lack of ceramic manufacture, a sealed
test element holder, and that complex and miniaturized forms are
possible.
According to a further embodiment of the present invention, the
analysis device according to the invention contains a measurement
module for carrying out a measurement on an analyte which is
contained on a test element, which measurement module comprises a
test element holder for holding the test element during the
measurement which test element holder contains a heat-treatment
device for heat-treatment of the test element, with the test
element holder with the heat-treatment device, which comprises
heating filaments and a spring contact, being an injection-molded
circuit mount, in particular a three-dimensional, injection-molded
circuit mount. The conductor tracks, which are used as heating
filaments, are therefore integrated directly in the plastic of the
test element holder by means of MID technology. The integration of
a ceramic heater is not essential. The sprung contacts, which are
likewise produced by the MID method, allow the heat-treatment
device to be connected to a printed circuit board for supplying
electrical power. There is therefore no need to use pins. As a
result, the entire production process for the heat-treatment device
is advantageously restricted to plastic molding by
injection-molding and to the application of the metallic structure
to the MID component. The advantages of this embodiment of the
analysis device according to the invention with a heat-treatment
device are simplification of the production process, avoidance of
the problems resulting from ceramic fracture, reduction in the
production costs owing to the lack of ceramic manufacture, a sealed
test element holder and that complex and miniaturized forms are
possible.
An analysis device for analysis of a sample on a test element
contains at least one test element holder in order to position a
test element before and during analysis (for example for holding
the sample and in particular for electrochemical or optical
analysis of the sample). According to one embodiment of the present
invention, the test element holder has at least two sprung contacts
which are used for positioning a test element in the test element
holder, with the test element holder with the at least two sprung
contacts being an injection-molded circuit mount (in particular a
three-dimensional, injection-molded circuit mount). The positioning
process can be carried out with the aid of a test element holder
such as this, for example in such a way that a metallic
electrically conductive structure (for example a metallic area)
which is provided on the test element shorts the at least two
sprung contacts as soon as the test element is located in the
desired position. An electric current can flow through the short
via the contacts, and can be detected and evaluated as a position
signal.
According to one embodiment of the present invention, the analysis
device according to the invention contains a contact element for
test element evaluation in the analysis device, in the form of a
component which makes electrical contact and is an injection-molded
circuit mount (such as a three-dimensional injection-molded circuit
mount). This contact element for test element evaluation can make
contact with a test element to be evaluated electrochemically.
Electrochemical methods for determining the concentration of an
analyte are based, for example on current or charge measurement.
Methods such as these are known, for example, from the documents
U.S. Pat. No. 4,654,197, EP 0 505 475 B or U.S. Pat. No. 5,108,564,
the disclosures of which are hereby incorporated by reference in
their entireties. Electrical signals must be transmitted between
the test element and the analysis system in order to carry out
electrochemical analysis. Electrical contact must therefore be made
with a test element that has been introduced into an analysis
system, in the analysis system with the aid of an electrical
connection system.
The prior art makes use of a plug connector as a contact element
for making contact, comprising a plastic part and metallic
elements. The plastic part is used as a housing and provides the
guide function for the test element. The metallic elements are used
for carrying electrical power and to make contact. The metallic
elements are produced by bending and stamping processes and are
either fitted to the plastic part or are molded directly in it. The
limitations for the design and configuration of a plug connector
result mainly from the restrictions of the stamping and bending
processes and the requirement to allow metal parts to be fitted and
extrusion-coated. As a result of the stamping and bending
processes, the configuration and design of the contact elements in
the prior art is greatly restricted in comparison to the
capabilities of plastic processes. In addition, the requirement to
allow metal parts to be fitted and to be extrusion-coated must be
taken into account in the design. In the analysis device according
to the invention, the function of making electrical contact is not
provided by fitted metal parts, but is provided by a contact
element produced using MID technology.
According to one embodiment of the invention, the analysis device
according to the invention contains a contact element for test
element evaluation, which contact element has a contact surface for
a test element, with a multiplicity of contact ramps projecting
over the contact surface and being intended to make electrical
contacts with a test element which is positioned on the contact
surface, and which can be connected to a printed circuit board via
conductor tracks which run on the contact element, with the contact
element being an injection-molded circuit mount, in particular a
three-dimensional injection-molded circuit mount. A test element
which is to be analyzed electrochemically can be moved in a slotted
guide of the analysis device on the contact surface of the contact
element until it is positioned on the contact ramps such that they
press against the test element and make contact with the electrical
contacts of the test element. By way of example, the contact ramps
may be in the form of projections, which are arranged on an
extension of the contact surface and are in the form of ramps, or
in the form of individual sprung contact lugs in the form of ramps.
The conductor tracks runs on the contact element, for example to
one end of the contact element, where they are soldered to the
printed circuit board in order to supply electrical power and for
signal processing.
According to one embodiment of the present invention, the contact
element for test element evaluation is integrated in the housing of
the analysis device, with the housing including the contact element
being an injection-molded circuit mount, such as a
three-dimensional injection-molded circuit mount.
According to another embodiment of the present invention, the
contact element for test element evaluation is integrated in a test
element magazine. In this case, an individual contact or a way of
making contact for all the test elements contained in the magazine
may be provided for each test element. An interface to the analysis
device is also located on the magazine. The test elements are
finally connected to the device via this interface. This embodiment
has the advantages that it allows a space-saving design since there
is no need for accurate positioning of the individual test elements
with respect to the analysis device, and the way in which contact
is made in the magazine can be designed to save costs, since all
that is necessary is a single way of making contact with the
restricted number of test elements contained in the magazine, and
the contact element is then disposed of with the magazine.
The present invention also relates to a supply container for at
least two test elements (test element magazine) with the test
elements having electrical conductor tracks and the supply
container containing electrical contacts for making contact with
the conductor tracks of a test element contained therein, during
the electrochemical analysis of a sample on the test element.
By way of example, the supply container is a test element magazine
which is in the form of a drum and, in particular, can be designed
largely in the same way as the supply container described in DE 198
54 3.16 A1, the disclosure of which is hereby incorporated herein
by reference in its entirety. The supply container according to the
invention has electrical contacts which are used to make electrical
contact with a test element to be evaluated electrochemically. The
supply container according to one embodiment of the present
invention has at least two separate chambers for holding the test
elements, with electrical contacts for making contact with the
conductor tracks of the respective test element contained therein
being arranged in each chamber during the electrochemical analysis
of a sample on the test element.
In the prior art, the electrochemical evaluation is carried out in
a measurement module of the analysis device, in which electrical
contact is made with the test element and which is arranged at a
distance from the test element supply container in the analysis
device. If required, the test elements are fed automatically
through a transport unit in the analysis device from the test
element supply container, are transferred to the measurement module
and are positioned accurately there, in order to make electrical
contact. One disadvantage of making electrical contact in this way
in a measurement module is, for example, that it requires a larger
physical space within the analysis device for electrochemical
analysis of the test element. Furthermore, the test element must be
positioned accurately, in order to make contact. The transfer of
the test element to the contact-making point in the analysis device
is a potential weakness in terms of positioning, reliability and
dynamic contact-making. The contacts of the measurement module in
the analysis device are also suitable only for one specific
electrode structure on test elements.
In contrast, the solution according to the embodiments of the
present invention has the advantage, which results from the
integration of the electrical contact-making process in the supply
container (test element magazine), that this allows a simple
interface, which can be standardized, between the analysis device
and the magazine, in which case the electrical contacts which, for
example, are arranged in the chambers of the respective magazine
can be matched to the electrode structure of the test elements
contained therein, and can be designed to be variable. This also
allows the analysis device and magazine to be designed to save
space. Furthermore, there is no need for accurate positioning of
the test element outside the supply container in the analysis
device. The process of making contact with the test elements in the
magazine can be designed to save costs, since it need make contact
only with the test elements contained in the magazine, and the
magazine can then be disposed of.
Contact can be made in the supply container via fitted or
extrusion-coated metal parts. According to one embodiment of the
present invention, the supply container according to the invention
with the electrical contacts is essentially an injection-molded
circuit mount, such as a three-dimensional injection-molded circuit
mount.
The necessary electrode structure for test elements to be evaluated
electrochemically is generally produced in the prior art by a
printing method or by laser ablation. This is done by first of all
producing the test element, and then applying the electrode
structure. This means that a three-dimensional configuration of the
test element is greatly restricted, or impossible. Relatively large
test elements can therefore be produced only with difficulty, with
multiple tests or tests for different parameters, since laser
ablation restricts the size of the illumination window, and
printing methods very greatly limit the design options.
The invention therefore also relates to a test element containing a
test area for electrochemical analysis of a liquid sample in an
analysis device, with the test area on the test element being
connected to electrical conductor tracks, and with the test element
with the electrical conductor tracks being essentially an
injection-molded circuit mount.
In the solution according to the invention, the electrode structure
is integrated in a plastic sample mount by means of an MID method.
This results in the advantages of a high level of design freedom
for the configuration of the test element (real 3D structures are
possible), a simple production process (injection-molding) and that
it is possible to produce large test elements with a large number
of test areas.
The invention also relates to a method for producing an analysis
device for analysis of a sample on a test element, containing at
least one component which makes electrical contact electrical power
transmission, which is suitable for making an electrical contact
with at least one further component for having the following steps:
producing the component which makes electrical contact and
comprises a base body and a metallic conductor structure, by means
of a method for producing injection-molded circuit mounts, and
positioning and mounting the component which makes electrical
contact in the analysis device in order to make an electrical
contact with the further component with which contact is made.
The method for producing injection-molded circuit mounts, typically
comprises one of the following methods: two-component
injection-molding, hot stamping, in-mold film coating and laser
structuring.
The invention is to be explained in more detail by the following
figures and examples.
BRIEF DESCRIPTION OF THE DRAWINGS
The following detailed description of the embodiments of the
present invention can be best understood when read in conjunction
with the following drawings, where like structure is indicated with
like reference numerals and in which:
FIG. 1.1 illustrates a perspective view of an analysis device from
the prior art.
FIG. 1.2 illustrates an exploded view of the analysis device from
FIG. 1.1.
FIG. 2 illustrates an exploded view of various functional
assemblies of an analysis device from the prior art.
FIG. 3.1 illustrates an exploded view of a prior art positioning
device for a test element magazine in an analysis device.
FIG. 3.2 illustrates an exploded view of an embodiment of a
positioning device for a test element magazine in an analysis
device according to the present invention.
FIG. 4.1 illustrates an exploded view of a prior art transport unit
for test elements in an analysis device.
FIG. 4.2 illustrates an exploded view of an embodiment of a
transport unit for test elements in an analysis device according to
the present invention.
FIG. 5.1 illustrates an exploded view of a prior art motor module
in an analysis device.
FIG. 5.2 illustrates a perspective view of an embodiment of a motor
holder of a motor module in an analysis device according to the
present invention.
FIG. 6.1 illustrates a perspective view of a prior art barcode
reader arrangement in an analysis device.
FIG. 6.2 illustrates a perspective view of an embodiment of a
barcode reader arrangement in an analysis device according to the
present invention.
FIG. 7.1 illustrates an exploded view of a prior art test element
magazine holder in an analysis device.
FIG. 7.2 illustrates a perspective view of an embodiment of a test
element magazine holder with a sensor in an analysis device
according to the present invention.
FIG. 8 illustrates a perspective view of a prior art contact
element for test element evaluation in an analysis device.
FIG. 9 illustrates a perspective view of an embodiment of a first
contact element for test element evaluation in an analysis device
according to the present invention.
FIG. 10 illustrates a perspective view of another embodiment of a
contact element for test element evaluation in an analysis device
according to the present invention.
FIG. 11.1 illustrates a perspective view of a prior art a
heat-treatment device in a measurement module of an analysis
device.
FIG. 11.2 illustrates a perspective view of the rear face of a
heating element from the prior art.
FIG. 11.3 illustrates a perspective view of the front face of a
heating element from the prior art.
FIG. 11.4 illustrates a perspective view of an embodiment of a
heat-treatment device in a measurement module of an analysis device
according to the present invention.
FIG. 12 illustrates a perspective view of an embodiment of a supply
container according to the present invention for test elements in
an analysis device.
FIG. 13 illustrates a perspective view of a first embodiment of a
test element according to the present invention, shown essentially
in the form of an injection-molded circuit mount.
FIG. 14 illustrates a perspective view of a second embodiment of a
test element according to the present invention, shown essentially
in the form of an injection-molded circuit mount.
In order that the present invention may be more readily understood,
reference is made to the following detailed descriptions and
examples, which are intended to illustrate the present invention,
but not limit the scope thereof.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION
The following descriptions of the embodiments are merely exemplary
in nature and are in no way intended to limit the present invention
or its application or uses.
The analysis device 1 has a housing 2 which contains a display area
3 (LCD 4) and a control area 5 (switch-on button 6). The test
element magazine holder 7 can be seen in the analysis device 1
illustrated in FIG. 1.1, because a test element magazine holder
cover has been removed. A test element magazine 8 which is in the
form of a drum and can hold a plurality of test elements is located
in the test element magazine holder 7. On the outside, the test
element magazine has a barcode 9 which contains information, for
example about the test elements contained in it, and which can be
read by a barcode reader (which is not illustrated). A measurement
process is started using the switch-on button 6. A motor (which
cannot be seen) rotates the test element magazine 8 further around
a chamber 10, and a second motor (which cannot be seen) uses a push
rod to move a test element 11 out of a chamber 10 of the test
element magazine 8 until it projects out of the analysis device 1.
In this position, a user can pass a sample (for example blood) to
the test element 11. Measurement optics (which cannot be seen) in
the analysis device 1 analyze the sample on the test element 11.
The analysis result (for example a blood glucose value) is
displayed on the LC display. A removable piercing aid 12 is fitted
at the side to the housing 2 of the analysis device 1, and can be
used to obtain samples.
FIG. 1.2 shows an exploded illustration of the analysis device from
FIG. 1.1.
From top to bottom, the illustration shows the test element
magazine holder cover 7, the upper housing half 14, the LC display
4, the printed circuit board 15, the measurement module 20, the
motor module 16, the lower housing half 17, the name plate 18, the
battery compartment cover 19 and the piercing aid 12. The lower
housing half 17 has a cover 21 which can be folded up and can be
opened and unlocked with the aid of the unlocking knob 22. A test
element magazine can then be inserted into, or removed from, the
test element magazine holder 7. The motor module 16 has a push-rod
motor module 23 and a magazine motor module 24. The magazine motor
module 24 has, inter alia, the drive wheel 27 which extends into
the test element magazine holder 7 and has a tooth system for
engaging in a test element magazine to be driven. The printed
circuit board 15 has a printed circuit board arm 25, which extends
into the test element magazine holder 7 and to which, inter alia, a
barcode reader 26 is attached.
FIG. 2 shows an exploded illustration of various assemblies of an
analysis device from the prior art.
The various assemblies have a plurality of electrical contacts for
electrical power transmission. For purposes of this disclosure,
"electrical power transmission" is intended to include transmission
not only of electrical power but also electrical signals; that is,
an electrical transmission between components for any useful
purpose, including providing or transferring power for operation of
a component or transmitting electrical signals used by a component,
such as electrochemical measurement signals.
For classification purposes, a distinction is drawn between sprung
contacts, plug contacts, solder contacts and sliding contacts. To
distinguish between them electronically, these contacts are
subdivided on the basis of the current load into signal
transmission and power current transmission. Furthermore, the
sprung contacts are mechanically subdivided into statically
springing and dynamically springing contacts. FIG. 2 shows the
various contact types which connect the assemblies motor module 16,
measurement module 20 and barcode reader 26 to one another and to
the printed circuit board (which is not illustrated). In detail,
FIG. 2 illustrates the following components:
a) A transport unit for test elements has a push rod 29, a guide
bush 30 and a guide device 31, in which the guide bush 30 can be
guided. The method of operation of the transport unit will be
explained in more detail with reference to FIG. 4.1.
b) A push-rod motor module 23 has a motor holder 28 and a motor
32.
c) A magazine motor module 24 likewise has a motor holder 28 and a
motor 32. The motor modules will be explained in more detail with
reference to FIG. 5.1.
d) A positioning device 33 for a test element magazine has a drive
wheel 27, a segmented disk 34 and a transmission board 35. The
positioning device will be explained in more detail with reference
to FIGS. 3.1 and 3.2.
e) A barcode reader arrangement 36 has a housing section 37 and a
barcode reader 26, which is attached to a printed circuit board arm
(which is not illustrated) which projects into the housing section
37. The barcode reader arrangement 36 will be explained in more
detail with reference to FIG. 6.1.
f) A measurement module 20 has a test element holder 38 and an
optics board 39.
Inter alia, the assemblies have the following electrical contacts:
battery contacts 40, magazine motor contact 41, push-rod motor
contact 42, measurement module contact 43, position switch contacts
44 for the drive wheel 27, push-rod switch contacts 45, sliding
contacts 46 for the drive wheel 27, test element contact 47 in the
measurement module 20, optics board contact 48 in the measurement
module 20, barcode reader contact 49, motor contacts 50 and a
magazine position contact in the form of the segmented disk 34.
This analysis device from the prior art has more than 67 contacts,
which are provided by more than 19 separate components. In the
analysis device according to the invention, these separate
components and the assembly steps associated with them can largely
be saved by integrating them in MID components which make
electrical contact.
FIG. 3.1 shows an exploded illustration of a positioning device for
a test element magazine in an analysis device from the prior
art.
The positioning device 33 has a transmission board 35, a metallic
segmented disk 34 and a drive wheel 27. The drive wheel 27 is
rotated with the aid of a motor (which is not illustrated). A test
element magazine (which is not illustrated) is also rotated by the
tooth system 52 on the drive wheel 27. In the prior art, the
rotation of the test element magazine is detected by the two
sliding contacts 46, which are hot-swaged on the transmission board
35, on the segmented disk 34. The signal is passed to a printed
circuit board (which is not illustrated) by means of two further
position switch contacts 44.
FIG. 3.2 shows a positioning device 33 for a test element magazine
in an analysis device according to the invention. Instead of having
five separate components, this positioning device has just two
components: the board 53 (component 123 which makes electrical
contact) which is an injection-molded circuit mount, and the drive
wheel 54 (component 124 which makes electrical contact), which is
likewise an injection-molded circuit mount. Spring contacts 55 are
integrated in the MID board 53, 123 and are used to make contact
with the segmented disk 56 and a further printed circuit board
(which is not illustrated). The segmented disk 56 is integrated in
the drive wheel 54, 124.
FIG. 4.1 shows a transport unit for test elements in an analysis
device from the prior art.
The transport unit 57 has a push rod 29 by means of which a test
element can be moved in the axial direction 58. The push rod 29 is
driven by a push-rod motor (which is not illustrated). The push rod
29 has a guide bush 30 which is guided in a longitudinal hole 59,
which is open at the top, in the guide device 31. A spacer 60 is
fitted to the guide bush 30 and projects upwards. A push-rod switch
contact 45 which is in the form of a metallic stamped and bent part
is mounted on the guide device 31. The three contact lugs 61 of the
push-rod switch contact 45 are pressed in three different positions
of the guide bush 30 in the longitudinal hole 59 through the spacer
60 upwards against the contact surfaces of a printed circuit board
(which is not illustrated), such that the respective position is
identified.
FIG. 4.2 shows a transport unit for test elements in an analysis
device according to the invention.
This transport unit also has a guide bush 62 for the push rod 29
(which is not illustrated), and a guide device 63 matched to it.
The guide device 63 contains a longitudinal hole 64, which is open
at the top, and in which the guide bush 62 is guided. The guide
bush 62 has contact lugs 65 which are sprung in the direction 66.
The guide bush 62 (component 125 which makes electrical contact)
with the contact lugs 65 connected via a spacer 67 is an
injection-molded circuit mount (MID). The guide device 63 is an
injection-molded part and has switching elements 68 which press the
contact lugs 65 upwards against contact surfaces on a printed
circuit board (which is not illustrated) in three different
positions of the guide bush 62. These three positions can therefore
be identified by the analysis device.
FIG. 5.1 shows an exploded illustration of a motor module in an
analysis device from the prior art.
By way of example, the motor module 69 may be a push-rod motor
module or a magazine motor module and has a motor 32 and a motor
holder 28. A contact plate 70 is pushed into the motor holder 28 in
order to supply electrical power to the motor 32, and makes an
electrically conductive connection to a printed circuit board
(which is not illustrated) via sprung contact lugs 71.
FIG. 5.2 shows a motor holder of a motor module in an analysis
device according to the invention.
The motor holder 72 (component 126 which makes electrical contact)
is an injection-molded circuit mount (MID). The motor holder 72 and
the electrical contacts, in the form of contact lugs 73 with the
conductor tracks 74 originating from them, are integrated in this
MID component which makes electrical contact. The contact lugs 73
can be soldered to a printed circuit board.
FIG. 6.1 shows a barcode reader arrangement in an analysis device
from the prior art.
A barcode reader 26 is attached to a printed circuit board arm 25
on the printed circuit board 15, is supplied with electrical power
via the printed circuit board 15, and emits signals via it. The
printed circuit board arm 25 also has further components 75, which
will not be explained in any more detail. The barcode reader 26 is
arranged on the printed circuit board arm 25 such that it projects
into a test element magazine holder (which is not illustrated) in
order to be able to read the barcode there, on the respectively
accommodated test element magazine.
FIG. 6.2 shows a barcode reader arrangement in an analysis device
according to the invention.
The barcode reader arrangement 76 comprises a housing section 76 of
the analysis device according to the invention, in which a barcode
reader 26 is arranged. The housing section 77 contains conductor
tracks 78, which run to the barcode reader 26, and sprung contacts
79 for making contact with a printed circuit board (which is not
illustrated). The housing section 77 (component 127 which makes
electrical contact) with the conductor tracks 78 and the sprung
contacts 79 is a three-dimensional, injection-molded circuit mount.
Since, in this embodiment, electrical power is passed to and from
the barcode reader 26 by the MID housing section 77, there is no
need for the printed circuit board arm 25 from the prior art (see
FIG. 6.1) (provided that a different solution is likewise found for
further components 75 in FIG. 6.1). This saves physical space in
the analysis device, and the printed circuit board can be produced
in more advantageous batches and with little scrap.
FIG. 7.1 shows a test element magazine holder in an analysis device
from the prior art.
A test element magazine 8 can be inserted into the test element
magazine holder 7. In the analysis device from the prior art, a
change of test element magazine 8 is registered by opening and
closing a test element magazine holder cover (which is not
illustrated), thus operating a locking switch 80. If the test
element magazine holder cover is opened and closed without the test
element magazine 8 being changed, then the analysis device
incorrectly registers that the test element magazine 8 has been
changed.
FIG. 7.2 shows a test element magazine holder with a sensor for
identification of a test element magazine change in an analysis
device according to the invention.
In the analysis device according to the invention, a change of test
element magazine 8 is identified when a mandrel sleeve 81 which
supports the test element magazine 8 at the point 82 has been
unlocked by a bolt 83, has been moved in the opening direction 84
and, after the test element magazine cover has been closed, has
been moved back again in the closing direction 85. A sensor 86 for
identifying this movement sequence is designed, for example, such
that a switching stud (which is not illustrated) on the mandrel
sleeve 81 makes a contact, and passes on the signal via spring
contacts 87 to the printed circuit board (which is not
illustrated). This largely avoids incorrect identification of a
change of the test element magazine 8. The test element magazine
holder 89 (component 128 which makes electrical contact) in this
embodiment contains the spring contacts 87 and conductor tracks 88,
which connect the spring contacts 87 to the sensor 86, and is a
three-dimensional injection-molded circuit mount (MID).
FIG. 8 shows a contact element for test element evaluation in an
analysis device from the prior art.
The contact element 90 is used to make electrical contact with a
test element which is to be evaluated electrochemically (but which
is not illustrated). The contact element 90 is foamed from a
plastic part 91 and metallic elements 92. The metallic elements 92
are produced by bending and stamping processes, and are fitted to
or directly injection-molded on the plastic part 91. In order to
make contact, a test element is moved in the direction of the
contact ramps 94 on the contact surface 93 until the contact ramps
94 press against contact surfaces which are provided on the test
element, and thus make contact with them. The contact lugs 95 are
firmly soldered to the printed circuit board in the analysis
device. The plugs 96 are used to align the contact element 90 while
it is being fitted in the analysis device. The design and
configuration of this contact element from the prior art are
subject to limitations resulting from restrictions in the stamping
and bending processes and the requirements to be able to fit and
extrusion-coat the metallic elements.
FIG. 9 shows a first contact element for test element evaluation in
an analysis device according to the invention.
This contact element 97 (component 129 which makes electrical
contact) is a three-dimensional injection-molded circuit mount
(MID). The conductor tracks 98 and contact ramps 99 are in the form
of electrically conductive areas directly on the injection-molded
plastic part 100. The conductor tracks 98 run from a contact lug
101, which can be connected to a printed circuit board, over a test
element contact surface 102 to the contact ramps 99. The contact
ramps 99 are formed by plastic projections on a surface of the
plastic part 100, with the metallic conductor tracks 98 running on
the plastic projections.
FIG. 10 shows a second contact element for test element evaluation
in an analysis device according to the invention.
This contact element 103 (component 130 which makes electrical
contact) is likewise a three-dimensional injection-molded circuit
mount (MID) with conductor tracks 98 and contact ramps 99 on an
injection-molded plastic part 100, which has a test element contact
surface 102. In contrast to the embodiment shown in FIG. 9,
separate contact lugs 104 and separate contact ramps 105 are in
this case provided for each of the conductor tracks 98.
FIG. 11.1 shows a heat-treatment device in a measurement module of
an analysis device from the prior art.
A ceramic heating element is mounted, or is incorporated directly
during the production process, in an analysis device housing half
106. The electrical connections 107 of the ceramic heating element
can be seen in FIG. 11.1.
The ceramic healing element 108 is shown from the rear face in FIG.
11.2 and from the front face in FIG. 11.3. For the sake of
simplicity, FIG. 11.3 shows only two of the four electrical
connections 107. The two connections 107 are connected to a heating
filament 109 on a ceramic plate 110.
FIG. 11.4 shows a heat-treatment device in a measurement module of
an analysis device according to the invention.
The measurement module 111 is arranged in the analysis device
housing half 112 and has a test element holder 113 in which a
heat-treatment device 114 is integrated. The test element holder
113 (component 131 which makes electrical contact) contains heating
filaments 115 and a sprung contact 116, and is a three-dimensional
injection-molded circuit mount.
FIG. 12 shows a supply container according to the invention for
test elements in an analysis device.
The supply container 117 is a test element magazine which is in the
form of a drum and has 17 separate chambers 118 for holding 17 test
elements 119 in the form of strips. The supply container 117 has a
barcode 120 on its outer face. The test elements 119 are test
elements 119 which can be evaluated electrochemically and are
provided with electrical conductor tracks 121. The supply container
117 according to the invention contains electrical contacts 122 in
each chamber 118, for the conductor tracks 121 to make contact with
the test elements 119 contained therein during electrochemical
analysis of a sample on the test element. The test element 119,
which is illustrated in FIG. 12 and projects partially out of the
supply container 117, is slightly bent, so that the conductor
tracks 121 arranged on it are pressed against the electrical
contacts 122 on the supply container 117, thus making contact.
However, contact may also be made when the test element 119 is
inserted completely in the supply container 117. By way of example,
in order to make contact, sprung contacts are also possible in the
chambers 118. The supply container 117 (component 132 which makes
electrical contact) may, for example, be a three-dimensional
injection-molded circuit mount (MID).
FIG. 13 shows a first embodiment of a test element according to the
invention which is essentially in the form of an injection-molded
circuit mount.
The test element 150 has a base body 151 composed of plastic. A
multiplicity of test areas 152 for electrochemical analysis of a
liquid sample are arranged on the base body 151. A dry chemical is
located on the test areas 152 and reacts with the liquid sample.
The test areas 152 are each connected on the test element 150 to
electrical conductor tracks 153 which end at one end in an
electrode structure 154 and at the other end in a contact structure
155. The electrode structure 154 in each case projects into a test
area 152, and the contact structure 155 is used for connection to
measurement electronics (which are not illustrated) for an analysis
device. The base body 151 with the electrical conductor tracks 153,
the electrode structure 154 and the contact structure 155 is an
injection-molded circuit mount (MID). The test element 150 is in
the form of a round disk on which the test areas 152 with
associated conductor tracks 153 are arranged concentrically. This
test element 150 can be rotated automatically or manually in an
analysis device to a position in which electrical contact is made
with a desired test area 152, and a sample provided thereon is
analyzed electrochemically.
FIG. 14 shows a second embodiment of a test element according to
the invention, which is essentially in the form of an
injection-molded circuit mount.
The test element 160 has a base body 161 composed of plastic.
Depressions 162 are formed in the base body 161 and can hold a
sample to be analyzed and, possibly, an analysis means. Electrical
conductor tracks 163 are provided for analysis of the sample and
end at one end in an electrode structure 164 and at the other end
in a contact structure 165. The electrode structure 164 in each
case projects into a depression 162, and the contact structure 165
is used for connection to measurement electronics (which are not
illustrated) for an analysis device. The base body 161 with the
electrical conductor tracks 163, the electrode structure 164 and
the contact structure 165 is an injection-molded circuit mount
(MID). The test element 160 is in the form of a quadrilateral
platelet. It contains six depressions 162. The electrical conductor
tracks 163 are arranged on the test element 160 such that all the
contact structures 165 are positioned in a restricted area on the
test element 160. This makes it easier to position the test element
160 in order to make electrical contact with the samples, which are
provided in different depressions, in an analysis device.
Injection-molded circuit mounts (Molded Interconnect Devices--MID)
and methods for their production are known from the prior art, for
example from DE 197 17 882 A1 or WO 00/67982 A1, the disclosures of
which are hereby incorporated herein by reference in their
entireties.
The expression MID technology covers various methods which can be
used to produce three-dimensional electronic assemblies. The aim of
these methods is integration of a circuit in a polymer (generally
thermoplastic) mount component.
If conventional solutions for making electrical contact and for
electronic circuits in devices are considered, spring contacts are
frequently found which are plugged-in, adhesively bonded or
hot-swaged in a housing (for example battery contacts in a large
number of small devices). Another variant is metallic leaf springs
or sliding contacts which make contact between the peripheral
electrical components and a printed circuit board (for example
sliding switches, push buttons or control wheels). The electronic
circuit which controls the device operation is generally provided
on a printed circuit board. The printed circuit board is fitted
with the required electronic components. In very simple circuits,
cables are soldered on or are connected to one another via plugs
for wiring. All of these construction and connection techniques
have the common feature that a plurality of components must be
automatically or manually positioned, joined and mounted in order
to construct a system which can operate. In this case, this results
either in a considerable amount of hardware complexity for
automated manufacture, or a considerable time penalty and labor
cost for non-automated manufacture.
The use of MID technologies for production of components which make
electrical contact in an analysis device in contrast offers the
capability to reduce these disadvantages of conventional solutions,
or to overcome them: assembly processes can be shortened or
entirely avoided. The number of components is reduced and tolerance
chains are shortened. Fewer different types of materials are used
in the device, thus simplifying disposal and recycling. Some MID
methods furthermore offer functions which are not possible with
conventional solutions.
MID methods are based on selective application of electrically
conductive metal layers on injection-molded plastic parts. A
metallized polymer injection-molded part such as this may include
electrical functions (for example the function of conductor tracks,
plug contacts or sliding contacts) and mechanical functions (for
example acting as an attachment element).
The most important MID methods which can be used to produce the
injection-molded circuit mount for the analysis device according to
the invention are two-component injection-molding, hot stamping,
in-mold film coating, and laser structuring.
In two-component injecting-molding, a thermoplastic material
component which can be metallized and a thermoplastic material
component which cannot be metallized are sprayed onto one another
in two process steps. In the final process, the work piece is in
this case held in the mold on the surfaces which have been provided
with their final contour during the first process. After
injection-molding, the surface of the thermoplastic which can be
metallized can be activated, and the desired metal layer thickness
(for example copper layer thickness) is applied chemically or
electrochemically. In the final step, a surface treatment is
applied, for example nickel-gold. The material component which can
be metallized has, for example, palladium admixed with it, which is
used as a seed for the metallization. The palladium seeds are used,
for example, as disintegration centers for stabilized nickel or
copper solutions. Plastics which can inherently be metallized are
used in other methods. A distinction is drawn in the metallization
methods between chemical metallization with no external electrical
power (without an electrical power source) and electrochemical
metal deposition (with an electrical power source connected).
Components which can be metallized and may be used for the
two-component injection-molding method are, for example, PES
(polyethersulfone), PEI (polyetherimide), LCP (liquid-crystal
polymer), PA (polyamide), PPA (polyphthalamide) or ABS
(acrylonitrile butadiene styrene). Components which cannot be
metallized are, for example, ABS+PSU (acrylonitrile butadiene
styrene+polysulfone), PPA (polyphthalamide), PBT
(polybutyleneterephthalate), PPS (polyphenylenesulfide), PES
(polyethersulfone), PC (polycarbonate) or PA (polyamide).
In the case of hot stamping, the metallic structure (for example
the conductor tracks) is applied in a process step after
injection-molding by stamping out and stamping a metal sheet (for
example a copper sheet) onto the plastic substrate. When using hot
stamping, vias can be produced by filling holes with a conductive
paste. In the case of hot stamping, the sheet must also be produced
in addition to the single-component injection-molding of the
substrate. Hot-stamping sheets for MID applications are generally
characterized by a three-layer structure composed of a conductive
copper sheet, an adhesive layer on the lower face and surface
metallization which is used as an oxidation layer and to improve
the capability for soldering and making contact. The copper sheets
are electrolytically deposited on a copper sulfate solution,
directly on a rotating titanium roller. The low shear strength of
the copper sheet which is required to cut out the metallic
structures (conductor tracks) in the stamping process is achieved
by a specific method technique for sheet production, which leads to
oriented crystal growth along the sheet surface. Copper sheets with
layer thicknesses of about 12, 18, 35 and 100 .mu.m are produced
before application of different current loads, with the typical
layer thickness that is frequently used for printed circuit board
technology being about 35 .mu.m. The adhesion strength of the sheet
on the substrate is achieved either by means of an adhesive layer
on the sheet lower face or by structuring of the sheet lower face.
Possible materials which can be used for hot-stamping are, for
example, ABS (acrylonitrile butadiene styrene), PA (polyamide), PBT
(polybutyleneterephthalate), PC+ABS (polycarbonate+acrylonitrile
butadiene styrene) and PPS (polyphenylenesulfide).
For in-mold film coating, the desired circuit is first of all
structured on a plastic film. By way of example, the film may be
structured using a subtractive flexible printed circuit technique,
or additively by means of primer technology or hot-stamping
processes. In flexible printed circuit technology, the polymer film
(for example composed of polyamide) is metallized over its entire
surface and is then structured using etching processes,
subtractively. When using primer technology, printing methods are
used to apply an adhesion promoter which can be metallized to the
plastic film.
After structuring, the film can be shaped and can then be in-mold
coated. The plastic part may be metallized before or after the
in-mold film coating.
The in-mold coated plastic film may, for example, contain PEI
(polyetherimide), PC (polycarbonate) or PC/PBT
(polycarbonate/polybutyleneterephthalate). Materials which may be
used for in-mold film coating of the film are, for example, PEI
(polyetherimide), PC (polycarbonate), PBT
(polybutyleneterephthalate), PET (polyethyleneterephthalate) or PEN
(polyethylenenaphtenate).
One further possible method for production of the
(three-dimensional) injection-molded circuit mount for the analysis
device according to the invention is laser structuring.
In subtractive laser structuring, the injection-molded work piece
is copper-plated, before structuring of the conductor tracks, over
its entire area first wet-chemically and then electrolytically
until the desired final layer thickness is achieved. An etching
resist is then applied to the copper layer, for example a
photoresist, in which energy introduced by means of UV radiation
initiates a chemical reaction, or a galvanoresist, which is removed
by means of laser beams. The resist is then structured by means of
a laser beam, and the copper is then etched away in the structured
areas. This is followed by surface treatment.
In additive laser structuring, thermoplastic materials are modified
such that a metal-organic complex compound is dissolved or finely
dispersed in the material. The conductor tracks to be produced on
the thermoplastics that have been doped in this way are then
specifically activated by means of a laser, and are then metallized
in a chemical bath. Chemical copper electrolytes which typically
produce copper layers with a thickness of about 5 to 8 .mu.m are
generally used for this process. A suitable surface finish can then
be applied.
Laser structuring can for example, be applied to PEI
(polyetherimide), PA (polyamide), LCP (liquid-crystal polymer), ABS
(acrylonitrile butadiene styrene), PC (polycarbonate), PC+ABS
(polycarbonate+acrylonitrile butadiene styrene), PBT
(polybutyleneterephthalate), PI (polyimide) or PET
(polyethyleneterephthalate), in which case the material may need to
be doped.
The features disclosed in the above description, the claims and the
drawings may be important both individually and in any combination
with one another for implementing the invention in its various
embodiments.
It is noted that terms like "preferably", "commonly", and
"typically" are not utilized herein to limit the scope of the
claimed invention or to imply that certain features are critical,
essential, or even important to the structure or function of the
claimed invention. Rather, these terms are merely intended to
highlight alternative or additional features that may or may not be
utilized in a particular embodiment of the present invention.
For the purposes of describing and defining the present invention
it is noted that the term "substantially" is utilized herein to
represent the inherent degree of uncertainty that may be attributed
to any quantitative comparison, value, measurement, or other
representation. The term "substantially" is also utilized herein to
represent the degree by which a quantitative representation may
vary from a stated reference without resulting in a change in the
basic function of the subject matter at issue.
Having described the present invention in detail and by reference
to specific embodiments thereof, it will be apparent that
modification and variations are possible without departing from the
scope of the present invention defined in the appended claims. More
specifically, although some aspects of the present invention are
identified herein as preferred or particularly advantageous, it is
contemplated that the present invention is not necessarily limited
to these preferred aspects of the present invention.
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